Surgical filament snare assemblies
10912549 · 2021-02-09
Assignee
Inventors
- Mehmet Ziya Sengun (Canton, MA, US)
- Howard Tang (Boston, MA, US)
- David B. Spenciner (North Attleboro, MA, US)
- Gregory R. Whittaker (Stoneham, MA, US)
- Gerome Miller (Randolph, MA, US)
- Joseph Hernandez (Sandwich, MA, US)
- Robert Stefani (New York, NY, US)
Cpc classification
A61B2017/0414
HUMAN NECESSITIES
A61B2017/0445
HUMAN NECESSITIES
A61B17/0485
HUMAN NECESSITIES
A61B2017/0458
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
International classification
Abstract
A surgical filament snare assembly including an anchor capable of being fixated in bone and having a filament engagement feature. A first filament has a noose with first and second noose limbs connected, preferably slidably connected, to the filament engagement feature of the anchor. The first and second noose limbs emerge from the anchor as first and second free filament limbs which are capable of being passed through tissue to be repaired and then passable through the noose. The noose, such as one or more half-hitches, is capable of receiving the free filament limbs and strangulating them when tension is applied to at least one of the free filament limbs and the noose to enable incremental tensioning of the tissue after the anchor is fixated. Preferably, the snare assembly further includes a flexible sleeve joining at least some portion of the first and second free filament limbs to facilitate passing of the free filament limbs at least through the tissue as a single unit.
Claims
1. A method for threading a surgical filament snare assembly, comprising: disposing one of a first filament or a first suture passer into a longitudinal channel of a first projection of a threader tool; disposing one of a second filament or a second suture passer into a longitudinal channel of a second projection of the threader tool; disposing a junction defined by the first filament or first suture passer being intertwined with the second filament or second suture passer in a common passage formed by a slot of the threader tool that extends between and is communication with the longitudinal channels of the first and second projections; and operating a stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool.
2. The method of claim 1, further comprising: intertwining the first filament or first suture passer with the second filament or second suture passer to define the junction between the first filament or first suture passer and the second filament or second suture passer.
3. The method of claim 1, wherein the longitudinal channels of the first and second projections each extend from a proximal terminal end to a distal terminal end of the respective first and second projections.
4. The method of claim 3, wherein disposing a first filament or first suture passer into a longitudinal channel of a first projection of a threader tool further comprises passing the first filament or first suture passer through the slot that is in communication with the longitudinal channel of the first projection from the proximal terminal end to the distal terminal end of the first projection, and wherein disposing a second filament or second suture passer into a longitudinal channel of a second projection of the threader tool further comprises passing the second filament or second suture passer through the slot that is in communication with the longitudinal channel of the second projection from the proximal terminal end to the distal terminal end of the second projection.
5. The method of claim 1, wherein the actions of disposing the first filament or first suture passer, the second filament or second suture passer, and the junction as recited results in a configuration in which: a distal end of the first filament or first suture passer extends out of a distal terminal end of the longitudinal channel of the first projection and a proximal end of the first filament or first suture passer extends out of a proximal terminal end of the longitudinal channel of the second projection, and a distal end of the second filament or second suture passer extends out of a distal terminal end of the longitudinal channel of the second projection and a proximal end of the second filament or second suture passer extends out of a proximal terminal end of the longitudinal channel of the first projection.
6. The method of 1, wherein operating the stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool further comprises pivoting the stop relative to the threader tool.
7. The method of claim 1, wherein operating the stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool further comprises: moving the stop in a first direction into a closed position to hold the first filament or first suture passer and the second filament or second suture passer within the longitudinal channels of the first and second projections; and moving the stop in a second, opposite direction into an open position to release the first filament or first suture passer and the second filament or second suture passer from the threader tool.
8. The method of 1, wherein operating the stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool further comprises overcoming a bias force supplied by the threader tool to release the first filament or first suture passer and the second filament or second suture passer from the threader tool.
9. The method of claim 1, further comprising: disposing at least one of the first filament, the second filament, or one or more filaments coupled to at least one of the first filament, the first suture passer, the second filament, or the second suture passer around at least a portion of a distal finger of the threader tool to hold the at least one of the first filament, the second filament, or one or more filaments coupled to at least one of the first filament, the first suture passer, the second filament, or the second suture passer.
10. The method of 9, further comprising disposing one of a loop or noose formed by at least a portion of one of the first filament, the second filament, or one or more filaments coupled to at least one of the first filament, the first suture passer, the second filament, or the second suture passer around the finger.
11. The method of 1, wherein the one of a first filament or a first suture passer is a first suture passer and the one of a second filament or a second suture passer is a second suture passer, the method further comprising: pulling the first suture passer through and out of one or both of the longitudinal channels of the threader tool to dispose a filament coupled thereto in the threader tool; and pulling the second suture passer through and out of one or both of the longitudinal channels of the threader tool to dispose a filament coupled thereto in the threader tool, wherein the filament coupled to the first suture passer and the filament coupled to the second suture passer become intertwined as a result of the pulling of the first and second suture passers.
12. The method of 11, further comprising: decoupling the filament from the first suture passer; and decoupling the filament from the second suture passer, wherein a half-hitch is formed between the filament that was coupled to the first suture passer and the filament that was coupled to the second suture passer as a result of the pulling of the first and second suture passers.
13. A method for threading a surgical filament snare assembly, comprising: disposing one of a first filament or a first suture passer into a longitudinal channel of a first projection of a threader tool; disposing one of a second filament or a second suture passer into a longitudinal channel of a second projection of the threader tool; disposing a junction defined by the first filament or first suture passer being intertwined with the second filament or second suture passer in a common passage disposed in a body of the threader tool, the common passage extending between and being in communication with the longitudinal channels of the first and second projections, and the common passage being in communication with a plurality of openings that are oriented external to each of the longitudinal channel of the first projection and the longitudinal channel of the second projection through which a portion of the first filament or the first suture passer and a portion of the second filament or the second suture passer extend external to the threader tool; and operating a stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool.
14. The method of claim 13, further comprising: intertwining the first filament or first suture passer with the second filament or second suture passer to define the junction between the first filament or first suture passer and the second filament or second suture passer.
15. The method of claim 13, wherein the longitudinal channels of the first and second projections each extend from a proximal terminal end to a distal terminal end of the respective first and second projections.
16. The method of claim 15, wherein disposing a first filament or first suture passer into a longitudinal channel of a first projection of a threader tool further comprises passing the first filament or first suture passer through a slot that is in communication with the longitudinal channel of the first projection from the proximal terminal end to the distal terminal end of the first projection, and wherein disposing a second filament or second suture passer into a longitudinal channel of a second projection of the threader tool further comprises passing the second filament or second suture passer through a slot that is in communication with the longitudinal channel of the second projection from the proximal terminal end to the distal terminal end of the second projection.
17. The method of claim 13, wherein the actions of disposing the first filament or first suture passer, the second filament or second suture passer, and the junction as recited results in a configuration in which: a distal end of the first filament or first suture passer extends out of a distal terminal end of the longitudinal channel of the first projection and a proximal end of the first filament or first suture passer extends out of a proximal terminal end of the longitudinal channel of the second projection, and a distal end of the second filament or second suture passer extends out of a distal terminal end of the longitudinal channel of the second projection and a proximal end of the second filament or second suture passer extends out of a proximal terminal end of the longitudinal channel of the first projection.
18. The method of 13, wherein operating the stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool further comprises pivoting the stop relative to the threader tool.
19. The method of claim 13, wherein operating the stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool further comprises: moving the stop in a first direction into a closed position to hold the first filament or first suture passer and the second filament or second suture passer within the longitudinal channels of the first and second projections; and moving the stop in a second, opposite direction into an open position to release the first filament or first suture passer and the second filament or second suture passer from the threader tool.
20. The method of 13, wherein operating the stop of the threader tool to at least one of selectively hold or release the first filament or first suture passer and the second filament or second suture passer from the threader tool further comprises overcoming a bias force supplied by the threader tool to release the first filament or first suture passer and the second filament or second suture passer from the threader tool.
21. The method of claim 13, further comprising: disposing at least one of the first filament, the second filament, or one or more filaments coupled to at least one of the first filament, the first suture passer, the second filament, or the second suture passer around at least a portion of a distal finger of the threader tool to hold the at least one of the first filament, the second filament, or one or more filaments coupled to at least one of the first filament, the first suture passer, the second filament, or the second suture passer.
22. The method of 21, further comprising disposing one of a loop or noose formed by at least a portion of one of the first filament, the second filament, or one or more filaments coupled to at least one of the first filament, the first suture passer, the second filament, or the second suture passer around the finger.
23. The method of 13, wherein the one of a first filament or a first suture passer is a first suture passer and the one of a second filament or a second suture passer is a second suture passer, the method further comprising: pulling the first suture passer through and out of one or both of the longitudinal channels of the threader tool to dispose a filament coupled thereto in the threader tool; and pulling the second suture passer through and out of one or both of the longitudinal channels of the threader tool to dispose a filament coupled thereto in the threader tool, wherein the filament coupled to the first suture passer and the filament coupled to the second suture passer become intertwined as a result of the pulling of the first and second suture passers.
24. The method of 23, further comprising: decoupling the filament from the first suture passer; and decoupling the filament from the second suture passer, wherein a half-hitch is formed between the filament that was coupled to the first suture passer and the filament that was coupled to the second suture passer as a result of the pulling of the first and second suture passers.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) In what follows, preferred embodiments of the invention are explained in more detail with reference to the drawings, in which:
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DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
(30) This invention may be accomplished by a surgical filament snare assembly including an anchor capable of being fixated in bone and having a filament engagement feature. A first filament has a noose, or a loop capable of being formed into a noose, on a first, proximal portion of at least a first limb and has a second portion connected, including slidably or fixedly connected, directly or indirectly, to the filament engagement feature of the anchor. The noose, such as one or more half-hitches, a Lark's Head knot, or a hangman-type noose, is capable of receiving at least one end of a free filament limb or a portion of another filament. The noose strangulates the free filament limb or other filament when tension is applied to the noose, to the free filament limb, and/or to the other filament.
(31) In certain preferred constructions, at least a first free filament limb, which in some constructions is a length of the first filament and in other constructions is a second filament, is passed through tissue to be repaired and has at least one end passable through the noose to enable incremental tensioning of the tissue after the anchor is fixated in bone. The present application is directed to one or more improvements described below beginning with
(32) Surgical filament snare assembly 10,
(33) First filament 14 has a noose 30 at its proximal end and a fixed knot 32 at the distal end of filament post or stem 15 which interacts with restricted opening 18 to retain filament 14 in a fixed, permanently attached position. This arrangement may be referred to as the first filament 14 connected with the filament engagement feature 18, which includes the phrase passing through the filament engagement feature 18. Many conventional knots, such as a mulberry knot, can be utilized for fixed knot 32 as long as knot 32 has sufficient bulk to prevent pull-through at clinically desired tensions on noose 30. A number of other types of filament engagements are described below. Stem 15 is kept as short as possible to maintain noose 30 close to anchor 12 even after it is collapsed as described below.
(34) A well-known noose knot 33 is illustrated in
(35) An alternative, simpler noose is illustrated for first filament 14b,
(36) Noose efficiency is defined herein as the strangulation strength per unit tension applied on the noose, either by pulling on the filament on which the noose is tied or which otherwise carries the noose, or by pulling on one or more strands or limbs of filaments passing through the noose. A noose with lower internal friction in the noose knot will tend to have a higher noose efficiency.
(37) One instrument for inserting anchor 12 into a hole drilled in bone is illustrated in
(38) In one procedure according to the present invention, anchor 12 is shown fixated within bone B,
(39) Continuing with this exemplary procedure, a second filament 60,
(40) When there is high noose efficiency, a light tug is sufficient to collapse noose 30 on the filament limbs 62 and 64 as shown in
(41) After initial or pre-tensioning of free filament limbs 62 and 64,
(42) Stopper knot 70 is advanced, typically using a knot pusher, until it contacts noose 30,
(43) Once satisfactory tissue tension has been achieved, one or more half hitches may be added to stopper knot 70 to fortify the loading capacity on the stopper knot and reduce the risk of loosening under adverse conditions. By comparison, conventional sliding knots typically are reinforced by at least two or three reversed half hitches placed on alternating posts. Due to the self-cinching effect of the present invention, fewer overall hitches or other knots are needed for stopper knot 70 to meet or exceed the load performance relative to conventional knot systems. The present invention thereby accomplishes a lower overall knot profile to handle a given load. Limbs 62, 64 are trimmed as desired. The stopper knot also minimizes fraying of the filament ends over time.
(44) Preferred materials for filaments 14 and 60 include various surgical sutures, typically size 0 to size 5, such as Orthocord suture commercially available from DePuy Mitek, and Ethibond suture available from Ethicon. Orthocord suture is approximately fifty-five to sixty-five percent PDS polydioxanone, which is bioabsorbable, and the remaining percent ultra high molecular weight polyethylene, while Ethibond suture is primarily high strength polyester. The amount and type of bioabsorbable material, if any, utilized in the first or second filament is primarily a matter of surgeon preference for the particular surgical procedure to be performed.
(45) While the same type of suture, even identical suture, can be used for both first, noose filament 14 and second, tissue filament 60, a suture having a lower abrasive property at its surface may be preferred by some surgeons for second filament 60. The lower abrasive property can be achieved by a larger diameter, a softer composition, a softer braid, plait or strand pattern, or a combination of such characteristics. The term braid as utilized herein includes plait and other multifilament patterns.
(46) The nooses illustrated in
(47) While two or more threader filaments, or careful, potentially tedious manipulation by a surgeon, could be utilized to achieve the configuration shown in
(48) Double-barrelled threader device 100,
(49) There are a number of other configurations of snare assemblies according to the present invention which have one or more adjustable-length noose support stems or limbs that enable the noose to be retracted as desired toward an anchor. These configurations provide an additional level of control over the final filament positions and tensions. Snare assembly 120,
(50) As illustrated in
(51) Snare assembly 140,
(52) In the procedure illustrated in
(53) Snare assembly 170,
(54) Snare assembly 190,
(55) Snare assembly 310,
(56) While most of the embodiments herein have been described in relation to securing one or two filament limbs passed through a single place or region in a tissue T, this is not a limitation of the invention. Snare assembly 210,
(57) One arrangement of the filament 192 for snare assembly 190,
(58) An example of steps for manufacturing snare assembly 190,
(59) Conventionally, rotator cuff lateral row fixation involves spanning a suture bridge from medial anchors. Sutures are fixated with knotted or knotless anchors at the lateral row. Unthreaded anchors suffer more often than threaded anchors from anchor pull out, and suture slippage may occur at relatively low loads in many conventional procedures regardless of anchor type.
(60) A presently preferred technique for rotator cuff double row repair is illustrated in
(61) Suture limbs 244, 246 from the medial row are then passed through noose 194,
(62) A simple knot such as a half hitch is then tied between suture limbs 244, 246 and pushed down against noose 194,
(63) Adjustable suture snare assembly 310,
(64) Suture anchor 312 has a proximal end 330 and a distal end 332 with opposed distal arms 334 and 336 defining cut-out 338 between them. Passage 340 is an inner lumen which runs from proximal end 330 to distal cut-out 338. Although knot 322 is shown extending beyond cut-out 338 in
(65) One or more bone-engaging features 342, such as the helical thread illustrated in
(66) It is a matter of surgeon preference whether a terminal end 318 is kept at a length sufficient to lie against the exterior of at least one bone-engaging feature 342 to be trapped against bone during insertion, or is trimmed to a shorter length. Further, a restriction such as restricted opening may be defined at least in part by engagement with bone when anchor 312 is fixated in bone to prevent knot 322 from moving with post limb 320 when tension is applied to post limb 320.
(67) One or more such distal extensions or other protrusions may be provided, similar in some constructions to Cauldwell et al. cited above or to U.S. Pat. No. 7,381,213 by Lizardi, also incorporated herein by reference. In yet other constructions, a cylindrical or otherwise circumferential cavity, bowl or countersink feature is provided at the distal end of the anchor to seat the knot 322 during insertion and fixation.
(68) Slidable knot 322 has been described as a bunt line half hitch knot in some constructions, but other suitable knots will be readily apparent to those of ordinary skill in the suture tying art after reviewing the present invention. The term slidable as used herein is intended to include slidable, lockable knots as well as slidable knots, such as those described in the Arthroscopic Knot Tying Manual (2005) available from DePuy Mitek, as well as the slidable, lockable knot by Wenstrom, Jr. in U.S. Pat. No. 6,767,037.
(69) Several improvements according to the present invention are illustrated in
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(71) Filament 400 with noose 402,
(72) It is a realization of the present invention that joining together at least the free filament limbs improves suture management and reduces the possibility of suture entanglement or damage by instruments, especially when passed through a cannula. For example, a surgeon or other user need only grasp and pass one sleeve 414 through noose 402 to thereby manipulate free filament limbs 424, 426 as a single unit. Additional convenience can be provided by perceptible indicators on one or more sleeves such as different markings, colors, diameters, braid or design patterns, or other tactile or visual indicia, especially if multiple tissue attachments or anchors are utilized, such as described above in relation to
(73) One technique for calculating the relative lengths of filament 501 and sleeve 508 is illustrated in
(74) For some constructions prior to implantation in a patient, sleeve 508 is twenty five inches in total length, with seven and one-half inches extending from the filament engagement feature of anchor 510 toward noose 504 as indicated by arrow 512, with seventeen and one-half inches, arrow 514, extending over and beyond free filament limbs 513 and 515 to proximal end 516 of sleeve 508. In one construction, filament 501 has a total length of thirty six inches, or a folded length of eighteen inches, with sixteen and one-half inches, arrow 520, extending from noose 504 to anchor 510, and one and one-half inches, arrow 522, as free limbs 513 and 515. In another construction wherein filament 501 has a total length of sixty six inches and a folded length of thirty three inches, free filament limbs 513, 515 extend sixteen and one-half inch as represented in phantom by arrow 524. In either construction, marks can be placed on the filament noose limbs 503, 505 nine inches from the center or middle, where noose 504 will be formed, to clearly indicate the proper positioning, arrows 502 and 512, of distal end 506 of the sleeve 508 over filament 501 during preparation of snare assembly 500 for implantation.
(75) A technique for utilizing the improved cinch noose 420,
(76) The proximal end of sleeve 414a is passed through tissue T,
(77) Materials for sleeves include braided sutures such as Ethibond size 0 suture or Orthocord size 2 suture, also referred to as Orthocord #2 suture, which is typically braided at sixty picks per inch. For use as a sleeve, a more relaxed braid of approximately thirty to forty picks per inch is preferred, more preferably about 36 picks per inch. If the sleeve material is formed about a core, preferably that core is removed to facilitate insertion of the filament limbs, which may themselves be formed of typical suture such as Orthocord #0 suture or #2 suture braided at sixty picks per inch.
(78) In yet another sleeve embodiment according to the present invention, one of the free filament limbs itself serves as the sleeve. For the construction illustrated in
(79) One technique for constructing snare assembly 540 is illustrated in
(80) One procedure for utilizing snare assembly 540 is shown in
(81) Another embodiment according to the present invention is illustrated in
(82) Second filament 574,
(83) After the noose 573 is formed with a Lark's Head knot, tail 580 and sliding knot 576 are passed through noose 573,
(84) Thus, when snare assembly 570 is supplied to a surgeon or other user with sliding knot 576 already tied, snare assembly 570 serves another example according to the present invention of a pre-formed, knot-less filament system which does not require the user to manipulate free limbs to tie knots during an operation. Adding to the benefits of snare assemblies according to the present invention, including high strength and loop security, low knot profile, ability to tension incrementally, and easy use with threaded anchors, providing a loop capable of forming a Lark's Head removes altogether the burden of tying a knot near or within a patient.
(85) In other words, a first filament, preferably a continuous fixed-length suture loop, is slidably attached to a collapsible filament loop of a second filament having a preformed sliding knot. In another construction shown in
(86) One or more tools can be utilized to assist creation of the constructs described above, especially if a half hitch is desired to be thrown on free filament limbs passing through different loops of a pretzel noose, that is, a noose with at least one half hitch that defines multiple loops through which the free filament limbs are passed. Improved threading tools and suture passers are illustrated in
(87) Suture passer 620 is shown in
(88) Intertwined suture passers 610 and 620 are shown held by threader tool 700 in
(89) In another construction shown in side view in
(90) Several threader tools according to the present invention having intersecting channels are shown in top view in
(91) Tool 900,
(92) Tool 1000,
(93) This invention may also be expressed as a surgical filament snare assembly with a bone anchor and a first filament having a noose, formed from at least one half hitch, on a first portion of at least a first limb and having a second portion connected to the filament engagement feature of the anchor. The noose is capable of receiving at least two free filament limbs and strangulating them when tension is applied to at least one of the free filament limbs and the noose. Preferably, the assembly further includes a threader tool having at least two projections having distal ends capable of being removably inserted into different loops of the half hitch. Each projection defines a channel capable of receiving a portion of at least one free filament limb to pass it through a loop of the half hitch, and each projection further defines a slot communicating with the channel to facilitate removal of the filament limb from the tool. Each slot has the same width as its corresponding channel in some embodiments and, in other embodiments, has a different width, typically a narrower width, than that of the corresponding channel.
(94) In certain embodiments, the projections are tubes joined together with at least one handle for manipulation the tube. The proximal ends of the channels are connected by one of an intersection and a common passage, and the tool further includes a stop as a proximal portion of the one of the intersection and the common passage. In some embodiments, the stop is movable, and may include a spring to bias the stop toward the intersection or common passage.
(95) In yet other embodiments, the assembly further includes at least two suture passers having distal ends for engaging portions of the free filament limbs, and the suture passers being capable of pulling the free filament limbs through the channels when proximal-directed force is applied to proximal ends of the suture passers. Preferably, the distal ends of the suture passers are intertwined in at least one half hitch to impart at least one half hitch to the free filament limbs when they are drawn through the tool. Different combinations selected from the group of an anchor, one or more filament constructs as described herein, a threader tool, and one or more suture passers can also be referred to as different kits according to the present invention.
(96) Thus, while there have been shown, described, and pointed out fundamental novel features of the invention as applied to a preferred embodiment thereof, it will be understood that various omissions, substitutions, and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all combinations of those elements and/or steps that perform substantially the same function, in substantially the same way, to achieve the same results be within the scope of the invention. Substitutions of elements from one described embodiment to another are also fully intended and contemplated. It is also to be understood that the drawings are not necessarily drawn to scale, but that they are merely conceptual in nature. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.
(97) Every issued patent, pending patent application, publication, journal article, book or any other reference cited herein is each incorporated by reference in their entirety.